Label: FOAMFRESH ALCO-FOAM HAND SANITIZER- alcohol liquid

  • NDC Code(s): 11429-1004-0, 11429-1004-1, 11429-1004-2, 11429-1004-3, view more
    11429-1004-4, 11429-1004-5, 11429-1004-6, 11429-1004-7, 11429-1004-8
  • Packager: Woodbine Products Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 17, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 62% v/v

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses:

    For hand sanitizing to decrease bacteria on the skin that could cause disease.

    Recommended for repeated use.

  • WARNINGS

    Warnings:

    Flammable. Keep away from fire or flame

    For external use only

    When using this product avoid contact with eyes.

    In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    Place enough product in your palm to thoroughly cover your hands.

    Rub hands together briskly until dry.

    Children under 6 years of age should be supervised when using this product.

  • STORAGE AND HANDLING

    Other information:

    Store below 110 F (43 C).

    May discolor certain fabrics or surfaces.

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, DEA-C8-18 Perfluoroalkylethyl Phosphate

  • PRINCIPAL DISPLAY PANEL

    Alco-Foam

    Hand Sanitizer

    Decreases common germs that

    can cause illness. Leaves skin

    soft and refreshed.

    Woodbine Products Company

    915 West Smith Road

    Medina, Ohio 44256

    www.woodbineproducts.com

    Made in the USA

    Stock # 4640         900 ml (31 fl. oz.)

    FoamFresh Alco-Foam

    Sanitizer

    container label

  • INGREDIENTS AND APPEARANCE
    FOAMFRESH ALCO-FOAM HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11429-1004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11429-1004-159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    2NDC:11429-1004-2250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    3NDC:11429-1004-31000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    4NDC:11429-1004-4900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    5NDC:11429-1004-51500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    6NDC:11429-1004-63785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    7NDC:11429-1004-7750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    8NDC:11429-1004-81250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    9NDC:11429-1004-0400 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/31/2014
    Labeler - Woodbine Products Company (004220323)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodbine Products Company004220323manufacture(11429-1004)
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